MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP; BONE FIXATION PLATE

Model Number KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Event Description

On 01/16/2024, it was reported by a sales representative via e-mail that an ar-2658tr knotless distal clavicle plate button tightropes button fell off the inserter tip.This occurred during a clavicle fx/cc ligament reconstruction on (b)(6) 2024 when the surgeon inserted the clavicle tightrope through the clavicle, before he could advance it through the coracoid, the button fell off the inserter tip.The button was retrieved from the patient.The case was completed using another tightrope.No harm came to the patient.The delay was about 10-20 minutes to retrieve the button from under the clavicle.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Type of Device: BONE FIXATION PLATE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 18669039
• MDR Text Key: 334909858
• Report Number: 1220246-2024-00852
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP
• Device Catalogue Number: AR-2658TR
• Device Lot Number: 15046879
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1